Two phase 3 trials showed that elinzanetant reduced VMS frequency and improved VMS severity at weeks 4 and 12<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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TUESDAY, Aug. 27, 2024 (HealthDay News) — For menopausal vasomotor symptoms (VMS), elinzanetant is efficacious and well-tolerated, according to a study published online Aug. 22 in the Journal of the American Medical Association<\/em>.<\/p>\n JoAnn V. Pinkerton, M.D., from the University of Virginia Health in Charlottesville, and colleagues examined the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate-to-severe menopausal VMS in two randomized, double-blind, phase 3 trials (OASIS 1 and 2), including postmenopausal participants aged 40 to 65 years. Eligible participants were randomly assigned to elinzanetant 120 mg for 26 weeks (199 and 200 in OASIS 1 and 2, respectively) or matching placebo for 12 weeks followed by elinzanetant 120 mg for 14 weeks (197 and 200 in OASIS 1 and 2, respectively).<\/p>\n The researchers found a significant reduction in VMS frequency with elinzanetant at week 4 (\u00e2\u0088\u00923.3 and \u00e2\u0088\u00923.0 in OASIS 1 and 2, respectively) and week 12 (\u00e2\u0088\u00923.2 and \u00e2\u0088\u00923.2 in OASIS 1 and 2, respectively). In addition, the severity of VMS was improved with elinzanetant at week 4 (\u00e2\u0088\u00920.3 and \u00e2\u0088\u00920.2 in OASIS 1 and 2, respectively) and week 12 (\u00e2\u0088\u00920.4 and \u00e2\u0088\u00920.3 in OASIS 1 and 2, respectively). Improvement in sleep disturbances and menopause-related quality of life was seen with elinzanetant at week 12, and the safety profile was favorable.<\/p>\n “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate-to-severe VMS,” the authors write.<\/p>\n Several authors disclosed ties to pharmaceutical companies, including Bayer, which manufactures elinzanetant and funded the OASIS 1 and 2 trials.<\/p>\n Abstract\/Full Text<\/a><\/p>\n